icumedical Cogent” Hemodynamic Monitoring System - Product Usage: intended for patients for whom the…
Medical device recall Z-0859-2021. Published in FDA’s Enforcement Report on Jan 20, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 20, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 19 states named
- 220 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
icumedical Cogent” Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
220 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List Number/Item Code: 58400-000 User Interface Module item: 58403-000 Serial Number: TSI701114 TSI701129 TSI701136 TSI701180 TSI701179 TSH901670 TSH200797 TSH901640 TSH900431 TSI701174 TSH200801 TSH200767 TSI701173 TSI802195 TSH101376…
Every code shown here, 1,997 characters
List Number/Item Code: 58400-000 User Interface Module item: 58403-000 Serial Number: TSI701114 TSI701129 TSI701136 TSI701180 TSI701179 TSH901670 TSH200797 TSH901640 TSH900431 TSI701174 TSH200801 TSH200767 TSI701173 TSI802195 TSH101376 TSH200764 TSH901982 TSH901985 TSH901602 THS901630 TSH901576 TSH901639 TSH901622 TSH901641 TSH901620 TSH901604 TSH901988 TSH901595 TSH901597 TSH901588 TSI701113 TSI701112 TSI701110 TSI701115 TSI701105 TSH900444 TSH900449 TSH901612 TSH901610 TSI701177 TSI701178 TSI701125 TSI701127 TSI701184 TSI701185 TSI701186 TSI701169 TSI701128 TSFA01684 TSFA01695 TSH101367 TSH901666 TSI701119 TSI701120 TSH901642 TSH901674 TSH901662 TSH901626 TSH901644 TSH901627 TSH901572 TSFA01683 TSH101379 TSH901643 TSH200798 TSH900438 TSH900411 TSH901594 TSH901991 TSH200832 TSH901648 TSH101337 TSH200780 TSH200763 TSH900406 TSH900409 TSH200802 TSH900434 TSH901581 TSH901636 TSH901632 TSH901619 TSH901647 TSH900446 TSH101358 TSH901615 TSH900417 TSH900442 TSH900429 TSH901987 TSH901609 TSH901590 TSH901638 TSI701106 TSI701107 TSI701100 TSI701121 TSFA01661 TSH101350 TSH200804 TSH200805 TSH101352 TSH101342 TSH101340 TSH101360 TSH900441 TSH901634 THS901589 TSH901573 TSH901603 TSH901657 TSH901575 TSH901655 TSH901608 TSH901984 TSH901599 TSH901579 TSH900423 TSH901664 TSH901617 THS901633 TSH901624 TSH901592 TSH901582 TSH901649 TSH901673 TSH901672 TSH901591 TSH901611 TSH901584 TSH901646 TSH901645 TSH901605 TSH901667 TSH901990 TSH901586 TSH901587 TSH901625 TSH901989 TSH901635 TSH900432 TSH901571 TSH101370 TSH200749 TSH900420 TSH200775 TSH200826 TSH200799 TSH900414 TSH901651 TSH200759 TSH901986 TSH901650 TSH901621 TSH901596 TSH901613 TSH901616 TSH900430 TSI701162 TSI701134 TSFA01681 TSH101383 TSH200820 TSH101364 TSH200765 TSH900433 TSH901631 TSI701138 TSH101365 140371 TSI802258 140123 140137 TSI701144 TSI701170 TSI701143 TSI701171 TSI701133 TSI701172 TSI701175 TSI701166 TSI701145 TSI701164 TSI701153 TSI701147 TSI701146 TSI701148 TSI701154 TSI701152 TSI701149 TSI701150 TSI701151…
FDA’s list runs to 5,214 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
U.S. Nationwide distribution including in the states of AL, AR, CA, CO, FL, IL, KY, MD, ME, MI, NC, NJ, OH, PA, TN, TX, VT, WA and WI. O.U.S.: None
The states and territories these words name
19 states and territories.
Every one of them
- Alabama
- Arkansas
- California
- Colorado
- Florida
- Illinois
- Kentucky
- Maryland
- Maine
- Michigan
- North Carolina
- New Jersey
- Ohio
- Pennsylvania
- Tennessee
- Texas
- Vermont
- Washington
- Wisconsin
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 9, 2020.
- FDA classified it on Jan 14, 2021.
- FDA’s Enforcement Report published it on Jan 20, 2021.
- FDA terminated it on Apr 19, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- ICU Medical, Inc., of San Clemente, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,214 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.